Indianapolis Defective Drug & Medical Device Attorneys
Defective & Dangerous Products
Products liability claims arise when a manufacturer sells products to consumers which are unreasonably dangerous or defective or fails to provide adequate warnings to consumers about known dangers associated with their products. These claims can cover a wide range of products, including consumer, commercial, and industrial products, pharmaceuticals (both prescription and over-the-counter), and medical devices. Each of these presents unique sets of issues impacting the potential for individuals injured by one of these products to recover compensation. Manufacturers fiercely fight these claims and hire teams of experienced defense attorneys to protect their profits – often at the expense of consumer safety.
We are proud that our work on behalf of clients has resulted in both financial justice for injured persons and their families, and put pressure on manufacturers to design safer products, pharmaceuticals, and medical devices. While no amount of money can ever fully compensate for a debilitating injury or the loss of a loved one, our clients, and our attorneys, take great satisfaction knowing that future consumers might not be put at the same risk.
Call us at (317) 576-3241 to speak to our defective drug attorneys in Indianapolis. We can help you better understand your circumstances and your options.
Defective Medical Products
Juul E-Cigarettes are the popular USB-shaped smoking device manufactured by Juul Labs and are the favorite choice for adult and teen smokers. Despite claims that e-cigarettes such as Juul are a safe alternative to traditional cigarettes, research indicates that Juul and other e-cigarettes actually expose users to a number of safety hazards associated with traditional cigarettes, in addition to hazards unique to e-cigarette use. Since its inception, Juul – which has captured an unprecedented 75% of the e-cigarette market estimated to be worth $86.43 billion by 2025 – has come under scrutiny after recent accusations that its aggressive social media marketing and fun, fruity, flavors deliberately target America’s youth in order to develop a new generation of smokers. The resulting “epidemic” of Juul and e-cigarette youth smokers has raised concerns in communities, states, and even federal agencies – resulting in the federal government labeling youth vaping as a “nationwide epidemic”.
Talcum Powder products have been used for decades on babies’ bottoms and by women in an effort to keep skin dry and avoid rashes. Perhaps the most iconic of these products, Johnson’s Baby Powder, has achieved almost universal recognition, thanks in large part to aggressive marketing and branding campaigns by its manufacturer – Johnson & Johnson – which tout this product as a safe and wholesome necessity for new mothers and adult women alike. However, since as early as the 1970’s, scientists have been looking at the connection between talc – the primary ingredient in talcum powder products – and ovarian cancer, and recent studies have shown that women who commonly apply talc products to the vaginal area have a 33% increased risk of developing cancer.
Concerns about the safety of talc stem from its close association with asbestos – a set of well-known cancer-causing minerals. Although manufacturers and trade associations claim that cosmetic grade talc has been asbestos-free since 1970, internal Johnson & Johnson documents and recent studies have shown that it is impossible to completely remove harmful asbestos in talc, and that industry testing standards are intentionally designed to overlook asbestos content. Despite years of denying any association between its products and asbestos, in October of 2019, Johnson and Johnson recalled 33,000 bottles of its iconic Johnson’s Baby Powder, after the FDA found evidence of asbestos in the products. Women across the country have brought claims against Johnson & Johnson alleging that their daily use of Johnson’s Baby Powder caused them to develop ovarian cancer, and juries have sided with these women. Hovde Dassow & Deets is proud to have been part of the trial team responsible for securing a $4.7 billion verdict against Johnson & Johnson in St. Louis on behalf of 25 women who developed ovarian cancer after daily use of Johnson’s Baby Powder.
Roundup is a popular weed killer that recent studies suggest could be deadly to more than just unwanted plants. A 2015 report from the World Health Organization’s International Agency for Research on Cancer found a potential link between the primary chemical component in the weed killer – glysophate – and Non-Hodgkin’s Lymphoma. While Monsanto disputes these claims, citing evidence from a number of in-house studies, as well as the United States EPA, documents obtained through litigation suggest that these studies are compromised as a result significant pressure by Monsanto on the EPA and its employees.
3M Combat Arms Earplugs were used exclusively by the US military between 2003 and 2013 to protect against hearing loss from gunfire, explosions, bombings, and other battlefield noises. These earbuds – which were intended to protect against hearing loss – have been shown to be too short for proper insertion into the ear, causing them to loosen. As a result, instead of blocking soundwaves as intended, they exposed America’s service men and women to potentially damaging noise, resulting in a range of injuries from tinnitus (ringing or buzzing in the ears) to partial or total hearing loss. This defect, which was known to manufacturers, was never disclosed to the government.
Benicar is a drug manufactured by Daiichi Sankyo to treat high blood pressure. The drug has been linked to sprue-like enteropathy and villous atrophy, intestinal problems that mirror the symptoms of Celiac disease. Specifically, the drug can cause intestinal damage, chronic diarrhea, malnourishment, and severe weight loss. In marketing Benicar, Daiichi Sankyo claimed that the drug was superior to competitors in both safety and effectiveness. However, recent studies show that no other drug in its class causes the severe intestinal issues associated with Benicar.
GranuFlo and NaturaLyte are drugs manufactured by Fresenius Medical Care, for use in dialysis centers to treat Americans with kidney disease or failure. Fresenius is the world’s largest provider of kidney dialysis services. On March 29, 2012, the FDA issued a Class I recall of these products to revise prescribing instructions after the products were found to cause low pressure and cardiac arrhythmia, which could result in heart attack. These concerns were cited in an internal Fresenius memo as early as November of 2011, which reported instances of nearly 900 patients experiencing heart attacks in Fresenius clinics during the previous year.
Victoza, Januvia, and Janumet are all members of a class of drugs known as increntin mimetics used to treat Type-2 Diabetes. People taking these drugs are at an increased risk of developing pancreatitis and pancreatic cancer. A study conducted by the Islet Research Center at the University of California, Los Angeles, found a six-fold increase in reported cases of pancreatitis linked to patients taking Januvia.
Onglyza and Kombiglyze XR are members of a class of medicines known as DPP-4 inhibitors used to treat Type-2 diabetes in individuals who do not have ketoacidosis. In recent years they have generated concern for harmful side effects associated with the drugs, including pancreatitis, pancreatic cancer, heart failure, congestive heart failure, and death. The FDA has opened investigations into the connection between these drugs and heart failure, as well as pancreatitis and pancreatic cancer.
Risperdal is an atypical antipsychotic manufactured by Johnson and Johnson for the treatment of schizophrenia. First approved in 1993, the drug has since been found to cause Gynecomastia, or the enlargement/development of breast tissue in males. This condition can be particularly harmful in children and adolescents since the condition is permanent and generally requires surgical removal and can lead to severe emotional trauma in adolescents.
Zantac, the popular over-the-counter and prescription heartburn medication has been the subject of recent FDA warnings linking the widely used medication to a risk of stomach and bladder cancer. Prescribed more than 15 million times per year, and routinely used by heartburn sufferers for decades, Zantac has recently been determined to contain unacceptably high levels of the carcinogen nitrosodimethylamine (NDMA) following testing of Zantac and its generic equivalent, ranitidine in September of 2019. Following these revelations, eight companies, including Kroger and Walgreens, have pulled Zantac from their shelves.
Defective Medical Devices
Hernia Mesh products are used in the treatment of hernias, which occur when a piece of internal tissue pushes through an opening in the flesh meant to contain that tissue. Synthetic hernia mesh products have come under scrutiny by the FDA and some manufacturers have withdrawn them from the market after numerous reports of defects and failures. When a hernia mesh product fails, it can result in pain, infection, recurrence of the hernia, formation of scar tissue, blockage in the intestine, bleedings, abnormal connection between organs, vessels, or the intestines, fluid build-up, or perforation of neighboring tissues and organs. A second surgery is typically required to remove, replace, or correct the defect.
Vaginal Mesh products are used in the treatment of women suffering from pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). When these products fail, they can cause significant pain with daily activities such as sitting, walking, and sexual intercourse. In addition to pain, vaginal mesh products can lead to erosion (when the implant damages vaginal walls and internal organs), infection, difficulty urinating, recurring prolapse, and recurring incontinence. Unfortunately, these implants are not easily removed, and in many cases, women suffering from complications associated with vaginal mesh must undergo multiple explant surgeries in order to completely remove the product.
Essure is a popular, permanent contraceptive device which has been implanted in more than 750,000 women worldwide. Despite being considered so dangerous that nearly every major market in the world has banned it, Essure remained commercially available in the United States until late 2018 when the manufacturer, Bayer, finally pulled it from the market. Although Essure is supposed to prevent pregnancy, in reality there have been an alarming number of reports of babies born while the mother was using Essure.
Mirena is a contraceptive device manufactured by Bayer Pharmaceuticals. It is designed to be used long-term and is placed inside the uterus to prevent pregnancy. Mirena has been linked to a number of dangerous injuries, including pseudotumor cerebra or intracranial hypertension. Mirena works by releasing a controlled dose of the hormone levonorgestrel and is one of the most common IUDs in the United States with over 2 Million women using the device since it was first introduced in 2000. Over that time, there have been approximately 70,000 complaints about dangerous side effects associated with the device reported to the FDA.
The Power Morcellator is a device used in laparoscopic surgery to blast tissue into small pieces for easy laparoscopic removal and is often used in hysterectomies or myomectomies. Approximately 1/350 of women undergoing a hysterectomy or myomectomy have an undiagnosed form of uterine cancer called uterine sarcoma. When a power morcellator is used in these surgeries, the device can blast the cancerous cells into the abdomen, facilitating the spread of this disease.
Hip implant litigation is a highly complex area of law requiring a great deal of experience navigating what is and is not a recoverable claim. Medical device manufacturers such as DePuy and Stryker hire teams of aggressive lawyers to help protect their interests – not the interests of injured patients. Hovde Dassow + Deets’ attorneys have significant experience handling hip implant cases, and are actively pursuing claims against the following manufacturers and products:
Stryker Orthopaedics has initiated a recall of specific lots and sizes of the LFIT Anatomic CoCr V40 femoral head manufactured by the company prior to 2011. The LFIT Anatomic CoCr V40 femoral head has been recalled due to higher than expected numbers of “taper lock” failures.
Taper lock failure puts patients at risk of experiencing a number of potential hazards, including:
- Separation of the femoral head from the femoral stem
- Fractured femoral stems
- Excessive release of metal or polymer debris
- Shortened length of the femoral neck
- Loss of range of motion
- Insufficient soft tissue tension
- Noise in the hip joint
The LFIT Anatomic CoCr V40 femoral head was used as a component in the Stryker Accolade hip replacement systems.
Stryker Orthopaedics also sold the Rejuvenate and the ABG II models of hip implant from 2009 to 2012, when they were recalled following thousands of complaints from injured patients. These models, which are made up of interchangeable parts, contained multiple metal-on-metal moving parts which grind together and release shards of metal and toxic chemicals into patients’ bodies. Despite knowing of these dangers, Stryker did not pull the products from the market and did not warn patients.
DePuy Orthopaedics, Inc.
Johnson & Johnson’s DePuy Orthopaedics, Inc. is the manufacturer of the ASR and Pinnacle hip replacement systems. Perhaps the most widely sold hip implants, DePuy has sold more than one hundred thousand ASR hip implant systems alone, despite knowing that the metal-on-metal ASR and Pinnacle systems had a high risk of failure, are prone to introducing toxic metal shards into the bodies of patients, and often require revision surgery to replace the implants after only a short period of time.
MicroPort Orthopedics, Inc. (PROFEMUR)
The FDA has issued a Class 1 recall for the PROFEMUR Neck Varus/Valgus CoCr 8 Degree. Class 1 recalls are issued by the FDA when there is a clear-cut risk to the health of patients, including the possibility of death. The recall was issued after the FDA determined there was a higher than expected instance of fractures related to the femoral neck of the implant.
Wright Medical Technology
Wright Medical Technology manufactured hip implant systems which have been the subject of hundreds of adverse event reports received by the FDA. These implants, which utilize metal-on-metal components, cause injury to patients when the moving metal-on-metal components grind against each other, releasing metal shards into the tissue surrounding the implants. The metal shards injury and irritate surrounding tissues, leach toxic chemicals into the body, and cause inflammation and corrosion of the surrounding soft tissue and bone.
Zimmer, Inc. manufactured the widely used Durom Cup implant. Before it was recalled by the FDA, the product was implanted in approximately 12,000 patients in the United States from 2006-2008. The implant had multiple moving metal-on-metal parts that ground against each other in the normal course of use, releasing toxic metal shards into the patient’s body. These metal shards cause inflammation, infection, and the decay of soft tissue and bone, resulting in severe pain to the patient. Surgery is required to remove and replace the implant, as well as treat the damage caused by the toxic metal shards.
Smith & Nephew
The Birmingham Hip Resurfacing (BHR) System is a metal-on-metal hip implant manufactured by Smith & Nephew for use in patients in need of partial hip resurfacing or complete hip replacement. The BHR System was widely used from 2006 until June of 2015, when it was pulled from the market following studies that showed the device caused an alarmingly high rate of complications and failures, requiring painful revision surgeries to remove and replace the implant.
We wanted to say thanks to Nick and the staff of Hovde Dassow + Deets for the excellent work you did as our attorney.- Dennis F.
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I can’t thank Nick Deets and his staff enough for assisting me with my personal injury case.- Beth R.